Medi-Fare Drug & Home Health Center, Inc.
Form 483 issued May 26, 2023 · Blacksburg, South Carolina
- Inspection
- May 15 – May 26, 2023
- Investigator
- Jared P. Stevens
- Observations
- 4
- Pages
- 3
- FEI number
- 3009925820
In short: On May 26, 2023, FDA issued a Form 483 with 4 observations to Medi-Fare Drug & Home Health Center, Inc. in Blacksburg, South Carolina (FEI 3009925820) after an inspection that ran May 15 – May 26, 2023. The investigator was Jared P. Stevens. Most observations concern materials and packaging & labeling; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and packaging & labeling account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 02
The identity of each component of a drug product is not verified by conducting at least…
- 03
Samples of representative lmits were not visually examined for coITect labeling at the completion of…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Jared P. Stevens
15 documents · 2017–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in South Carolina.
The firmMedi-Fare Drug & Home Health Center, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84(d)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medi-Fare Drug & Home Health Center, Inc.?
FDA listed 4 observations on this Form 483, mostly about materials, packaging & labeling and facilities & equipment. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Medi-Fare Drug & Home Health Center, Inc.?
Jared P. Stevens is named on this Form 483, for the inspection of May 15 – May 26, 2023. Each investigator has a profile showing what they cite most.
When was Medi-Fare Drug & Home Health Center, Inc. inspected by FDA?
The inspection ran May 15 – May 26, 2023, and the Form 483 is dated May 26, 2023.
How do I get the full Form 483 for Medi-Fare Drug & Home Health Center, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.